Birth control pills containing drospirenone are linked to a higher risk of stroke, the FDA (Food and Drug Administration) has announced today. The Agency explains that it has completed its review of recent epidemiologic studies. Drospirenone, a synthetic version of progesterone, a female hormone, is often referred to as progestin.

The FDA concluded that birth control pills that contain drospirenone are linked to a higher blood clot risk, compared to other pills which contain progestin. Drospirenone-containing contraceptive pills will have details regarding this risk added to their labels.

It is important that patients discuss blood clot risks with their doctors before deciding upon which birth control method to adopt, the FDA stressed. Also, doctors should weigh the risks versus benefits of birth control medications that contain drospirenone, including blood clot risks, before prescribing these contraceptives.

Consistent estimates comparing the blood clot risks between drospirenone-containing birth control pills and those without drospirenone were not provided in the studies. Neither did the studies account for key patient characteristics that may impact on blood clot risk and may influence prescribing. It is therefore not possible to tell whether the raised blood clot risk in some of the epidemiologic studies is really due to birth control pills which contain drospirenone, the FDA added.

The updated labels for Yaz, Yasmin, Safyral and Beyaz inform that a number of studies revealed a threefold rise in blood clot risks for those taking drospirenone-containing contraceptives, compared to others which contained levonorgestrel and some other progestins, while other studies detect no higher risk.

The FDA emphasized that any birth control pill taken long-term raises the risk of blood clots, compared to not taking them. The risk of developing clots during and immediately after pregnancy is higher, though.

The illustration below shows the risk of developing a blood clot for non-pregnant females who are not on birth control pills; for those using birth control pills; for pregnant mothers; and for postpartum women. E.g., if 10,000 non-pregnant adult females who are not on birth control pills are monitored for 12 months, between 1 and 5 of them will develop a blood clot. (COC = combination oral contraceptives or birth control pills)

bloodclotrisk

Table 1. Approved Oral Contraceptives Containing Drospirenone

Brand name

Generic name

Beyaz

Drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg

Drospirenone and ethinyl estradiol

Drospirenone 3 mg and ethinyl estradiol 0.03 mg

Drospirenone and ethinyl estradiol

Drospirenone 3 mg and ethinyl estradiol 0.02 mg

Gianvi

Drospirenone 3 mg and ethinyl estradiol 0.02 mg

Loryna

Drospirenone 3 mg and ethinyl estradiol 0.02 mg

Ocella

Drospirenone 3 mg and ethinyl estradiol 0.03 mg

Safyral

Drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg

Syeda

Drospirenone 3 mg and ethinyl estradiol 0.03 mg

Yasmin

Drospirenone 3 mg and ethinyl estradiol 0.03 mg

Yaz

Drospirenone 3 mg and ethinyl estradiol 0.02 mg

Zarah

Drospirenone 3 mg and ethinyl estradiol 0.03 mg

Written by Christian Nordqvist